The main purpose of this study is to see if a drug called aldesleukin, can preserve insulin production in children and young adults recently diagnosed with type 1 diabetes. One group will receive aldesleukin and the other a placebo.
Investigators know that the longer people with diabetes can produce their own insulin, the better it is for the control of their blood glucose levels and long-term complications. People get type 1 diabetes because their immune system, the part of the body, which helps fight infections, mistakenly attacks and destroys the beta cells in the pancreas that produce insulin. As the immune system destroys these insulin-producing cells, the body's own ability to produce insulin decreases and diabetes develops. At diagnosis, there are usually a small number of beta cells (10-20%) left in the pancreas, which still produce small amounts of insulin. This is called 'beta cell function' and it is assessed by measuring C-peptide, which is a protein made by the pancreas when insulin is produced. Most people with type 1 diabetes eventually stop producing insulin themselves, this may occur rapidly in a few months, or more slowly over several years. New treatments preserving insulin production could improve management of diabetes. This could be done by using drugs acting on cells of the immune system. In type 1 diabetes, there is an imbalance between cells of the immune system, and there is evidence that one protein produced by our body, called Interleukin-2, could help in resetting the balance between those cells. It is important to start this treatment soon after diagnosis because this when there is the best chance of saving the beta cells still left in the pancreas.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
41
PROLEUKIN® 18 x 106 IU Powder for solution for injection or infusion
sterile diluent used for the aldesleukin preparation and 5% glucose
Oxford Children's Hospital
Oxford, Oxfordshire, United Kingdom
Bristol Royal Hospital for Children
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
The Great North Children's Hospital
Newcastle upon Tyne, United Kingdom
Differences in slopes of DBS (Dried Blood Spot) C-peptide over the 6 month-treatment period between the active and placebo groups.
Time frame: Weekly DBS C-peptide collected during the 6-month treatment period, and then monthly during the 6 months of follow-up
Change in Treg, Teff and NK56bright cell frequencies and phenotypes from baseline
Time frame: At baseline and then1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (reported reactions using CTCAE grading v5.0)
Assessment of the most commonly reported reactions to low- or high-dose aldesleukin, namely influenza-like syndrome, skin reaction, diarrhoea, nausea using CTCAE grading v5.0
Time frame: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (temperature in celsius)
Vital signs - temperature in celsius
Time frame: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (weight, in kilograms)
Vital signs - weight, in kilograms
Time frame: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (blood pressure: systolic/diastolic)
Vital signs - blood pressure: systolic/diastolic
Time frame: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (heart rate: bpm)
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Nottingham Children's Hospital
Nottingham, United Kingdom
Vital signs - heart rate: bpm
Time frame: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (AST, ALT, ALP, GGT units per liter (U/L)
Abnormal laboratory parameters liver function (AST, ALT, ALP, GGT units per liter (U/L)
Time frame: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit total bilirubin - milligrams per deciliter (mg/dL)
Abnormal laboratory parameters liver function total bilirubin - milligrams per deciliter (mg/dL)
Time frame: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (urea and creatinine - mmol/L)
Abnormal laboratory parameters kidney function (urea and creatinine - mmol/L)
Time frame: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Safety will be assessed at each visit (full blood count - 109/L)
Abnormal laboratory parameters full blood count - 109/L
Time frame: At screening, baseline and then 1, 2 , 3, 6 and 12 months from the beginning of treatment
Changes in the absolute numbers of T, B and NK (Natural Killer) cells.
Time frame: At baseline and then, 1, 2 , 3, 6 and 12 months from the beginning of treatment
Change in HbA1c and daily insulin requirements during the trial period.
Time frame: HbA1c - At baseline and then 3,6 and 12 months Insulin dose data -Baseline and then 1, 2, 3, 6 and 12 months